JOHN F. KEENAN: With Zohydro, let's not condemn another generation to addiction

Monday

Mar 24, 2014 at 3:26 AMMar 25, 2014 at 3:19 AM

Two years ago I wrote to the FDA, urging it not to approve Zohydro, a powerful, non-tamper-resistant prescription painkiller, but Zohydro was approved this past October. Now we need to take steps to prevent the over-prescribing of Zohydro and ensure that we are not condemned to the tragic past of prescription painkillers.

"Those who cannot remember the past are condemned to repeat it.”

In 1995, the Food and Drug Administration approved a powerful prescription painkiller known as OxyContin. It was not tamper-resistant, meaning it could be easily crushed or manipulated for abuse.

By 1996, $48 million worth of OxyContin was sold. Four years later, sales topped $1 billion, and OxyContin was on its way to becoming the best-selling narcotic pain reliever in the United States. And America wasn’t just turning to OxyContin, it was turning to other prescription opioids as well, including Vicodin and Percocet.

According to the National Institute on Drug Abuse, from 1996 to 2010, the number of opioid prescriptions per year in the United States rose from 96 million to 210 million. Not surprisingly, the number of overdose deaths from prescription opioids also climbed, and by 2007 such deaths outnumbered deaths from heroin and cocaine combined. Today in Massachusetts, we lose more lives to opiate addiction each year than to gun violence and motor vehicle accidents.

That’s the past. Today, expensive prescription opioid addictions lead to cheaper heroin addictions, which in turn lead to fatal overdoses.

Two years ago, I wrote to the FDA, urging it not to approve Zohydro, a powerful, non-tamper-resistant prescription painkiller. Several of my State House colleagues joined me in this effort, and our message was carried to Washington by our congressional delegation. The combined voices of our elected state and federal officials were ignored, and Zohydro was approved last October.

The FDA’s approval of Zohydro is both alarming and disappointing, but it doesn’t necessarily mean we are doomed to the same fate that followed the approval of OxyContin. While I wish we could just ban Zohydro and all other non-tamper-resistant opioids here in Massachusetts, legally and practically such action would have to take place at the federal level. I commend U.S. Reps. Stephen Lynch and Bill Keating, and the entire Massachusetts congressional delegation for pursuing this course. Meanwhile, we can put the lessons of past experiences to use by implementing a logical prescribing protocol that will serve to avoid the same devastation fueled by OxyContin.

Purdue Pharma, the manufacturer of OxyContin, extensively and aggressively marketed the drug to a broad range of practitioners, leading to it being widely prescribed for conditions beyond its intended use. Learning from this, we should require that Zohydro be prescribed only by physicians who are board-certified in select specialties – for instance, oncology and pain management – and who have obtained a special license.

Consequently, emergency department physicians and dentists in any settings would not be permitted to prescribe Zohydro.

We also know that physicians learned about OxyContin primarily from Purdue Pharma. Given this, we should require physicians seeking the special licenses to prescribe Zohydro to complete an educational program developed by the Board of Registration in Medicine that specifically focuses on balancing pain management against addiction risks.

As stated, we know that OxyContin was widely prescribed inconsistently with its indicated use. Learning from this, we should ensure that physicians document in patients’ medical records that lower-risk alternative drugs and treatments were unsuitable, or were tried and failed, and that the use of Zohydro is medically necessary.

As the abuse of OxyContin became more prevalent, abusers would doctor shop, i.e. seek prescriptions from different physicians. Learning from this, two years ago we passed legislation requiring physicians to enroll in the state’s Prescription Monitoring Program (PMP) on a rolling basis, and requiring that they use it when prescribing a painkiller to a patient for the first time. We should require that physicians prescribing Zohydro not only be enrolled in the PMP, but that they use the PMP each time prior to writing a Zohydro prescription.

We also know that out-of-state prescriptions contributed to the painkiller epidemic. Learning from this, pharmacists should not be allowed to fill out-of-state prescriptions for Zohydro.

John F. Keenan represents Abington, Braintree, Holbrook, Quincy and Rockland in the Massachusetts Senate.
Since the approval of OxyContin back in 1995, we have the ability through the PMP to better track the prescribing of painkillers. With Zohydro, we should require the PMP to specifically track and audit the prescribing of Zohydro, reporting any possible prescribing violations to the Board of Registration in Medicine.

After its initial approval, OxyContin was further approved in increasing dosages and ultimately in a tamper-resistant form, which was then protected by patent; the result has been the dampening of the tamper-resistant generic market. To avoid similar issues in the future, we should ensure over the longer term that whenever a prescription for a non-tamper-resistant painkiller is written in Massachusetts, a pharmacist must substitute a tamper-resistant form if it is available.

History shows that we failed to anticipate the advent and growth of OxyContin and its contribution to the current opiate epidemic. By taking the above logical, cost-efficient steps, we can limit the over-prescribing of Zohydro and ensure that we are not condemned to the tragic past of prescription painkillers.